nafld policy review 2019 - virology education

NAFLD POLICY REVIEW 2019

Second International Conference on Fatty Liver Berlin, Germany

29 June 2019

Prof. Jeffrey V. Lazarus [[email protected]]

Associate Research Professor, ISGlobal, Hospital Clínic

Associate Professor, Faculty of Medicine, University of Barcelona

Vice-chair, EASL International Liver Foundation

@JVLazarus

Conflict of Interest DisclosureJeffrey V Lazarus, PhD, MIH, MA

Reports that this study was carried out on behalf of the EASL International Liver Foundation, which received funding from Gilead Sciences Europe Ltd, Allergan Pharmaceuticals, Pfizer Inc., Bristol-Myers Squibb and Resoundant, Inc.

Prof Lazarus received no funding for this work.

NAFLD Policy Review

3

OBJECTIVES

• Raise awareness about NAFLD/NASH across

Europe and abroad;

• Evaluate the extent to which European

Union member countries have key policies

and guidelines in place to address

NAFLD/NASH;

• Identify the gaps and opportunities for

improvement in NAFLD/NASH policies and

guidelines;

• Mobilize follow-up action including an

international coalition.

EASL INTERNATIONAL LIVER FOUNDATION 5

The EASL International Liver Foundation

PILLAR

PILLAR

PILLAR

RESEARCH EDUCATION

INTERVENTIONS AWARENESS

Jordi Bruix is Professor of Medicine

at the University of

Barcelona and Director

of the Barcelona Clinic

Liver Cancer (BCLC)

Group within the Liver

Unit at the Hospital

Clinic of Barcelona, Spain

Andrea Sironi is Professor of Banking

and Finance at Bocconi

University in Milan. He is

Chairman of Borsa

Italiana SpA and,

member of the Board of

Directors of the London

Stock Exchange Group.

Tom H. KarlsenMD, PhD, Full Professor

of Internal Medicine,

Oslo University Hospital

Rikshospitalet, Norway.

Secretary General of

EASL, Geneva,

Switzerland

Benoit MerktDr. iur., Attorney at Law,

MJur has been a partner of

the Swiss law firm Lenz &

Staehelin since 2006. He is

co-head of Lenz & Staehelin

competition law and non-

profit/philanthropy

practices.

Massimo ColomboMD, Professor of Medicine,

Head of Traslational Liver

Research, IRCCS,

Humanitas, Milan, Italy,

Chairman, EASL

International Liver

Foundation, Geneva,

Switzerland

Christian BréchotFranceMD Ph.D, is retired

President, Institut Pasteur,

Paris,

MISSION THE BOARD OF DIRECTORS

The EASL International Liver Foundation is a

global non-profit organization, established by

the European Association for the Study of the

Liver (EASL), committed to increasing the

quality of life and reducing premature

mortality for the greatest number of people

by improving liver health. 4 pillars guide our

action:

Jeffrey V. Lazarusis associate researcher

at the Barcelona

Institute of Global

Health (ISGlobal),

Hospital Clínic, and

Assoc Professor at the

University of Barcelona,

Vice Chairman EASL

International Liver

Foundation, Geneva,

Switzerland.

Stefan Wiktoris Professor of Medicine

and Public Health at the

University of

Washington in Seattle,

U.S. He was the Team

Lead of the World

Health Organization’s

Global Hepatitis

Programme in Geneva,

Switzerland.

Manal El SayedProfessor of Paediatrics at

Ain Shams University, Cairo,

Egypt. Since 2011 Vice Chair

of the WHO’s Technical

Advisory Group for

Prevention and Control of

Hepatitis in Egypt and

sViralupervisor (oversight) of

the Egyptian national

program for control of viral

hepatitis at Ministry of

Health.

Mark Thurszis Professor of

Hepatology at Imperial

College where he is

head of the Digestive

Diseases Division and

lead clinician for

hepatology at St Mary’s

Hospital, London,UK.

Philip N. NewsomeDirector of the Centre for

Liver Research & Professor

of Experimental

Hepatology, University of

Birmingham, and

Consultant Hepatologist at

the Liver Unit, Queen

Elizabeth Hospital,

Birmingham, Vice-Secretary

General of EASL, Geneva

Switzerland

4 PROGRAM PILLARS

HCV treatment timeline

Sources: Pawlotsky JM, et al. J Hepatol 2016; 62: S87–99; Manns M, et al. Nat Rev Dis Primers 2017;3:1–19.

Early era of DAAs

TVR

BOC

SMV

SOF

Identification

of HCV

IFN + RBV

The IFN era

IFN Peg-IFN + RBV

Pan-genotypic era

SOF/VEL G/P

SOF/VEL/VOX

DCVLDV/SOF

OBV/PTV/r + DSV

EBR/GZR

“DAA revolution”

“non-A, non-B”

hepatitis

1984 1989 1998 2001 2013 2014 2015 2016 2017…2011 Elimination?

Barriers: Minimum fibrosis stage required for re-imbursement of interferon-free DAA treatment naïve patients with HCV infection in Europe

Source: Marshall, AD et al. Restrictions for reimbursement of interferon-free direct acting antiviral therapies for HCV infection in Europe. Lancet GastroHep, 2017.

31% (n=11) of countries

required evidence of F2

17% (n=6) of countries

required evidence of F3

a Fibrosis stage restrictions based on HCV genotype

b Fibrosis stage is included in a point system for prioritisation of DAA therapy

c Fibrosis stage restrictions based on HCV genotype and IL28B polymorphism

d Fibrosis stage restrictions based on HCV therapy

Since Nov 2017: Belgium,

Denmark Finland Israel,

Luxembourg, Scotland and

Sweden have removed

restrictions.

New global political will to eliminate HCV

Sources: World Hepatitis Summit 2015 meeting report. Available at: http://www.worldhepatitisalliance.org/sites/default/files/resources/documents/World%20Hepatitis%20Summit%20Report.pdf; Elimination manifesto. Available at: http://www.hcvbrusselssummit.eu/elimination-manifesto (both accessed January 2017)

First World Hepatitis Summit (2015)84 countries represented – repeated in 2017

Hepatitis C Elimination in Europe (2016 + 2018)

‘Our vision for a Hepatitis C-free Europe’

World Health Assembly resolutions (2010,

2014)Patient community

delivers NOhep (2016)

WHO Global Health Sector Strategy on Viral Hepatitis 2016–2021

Source: WHO Global Health Sector Strategy on viral hepatitis. Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_32-en.pdf?ua=1 (Accessed August 2016)

28 May 2016: The first of

its kind, WHO publishes a

global strategy aiming for

elimination of viral

hepatitis as a public health

threat by 2030

The NAFLD spectrum

NASH Fibrosis CirrhosisHealthy

liver

Non-alcoholic fatty liver (NAFL, steatosis)

>5% hepatic steatosis, in the absence of other liver diseases

NAFL

9

The NAFLD spectrum

NAFL NASH Fibrosis CirrhosisHealthy

liver

Non-alcoholic steatohepatitis (NASH)

Hepatic steatosis with hepatocyte damage

10

NAFLD/NASH, a

multisystem

disease

Sources: Adams, L.A., Anstee Q.M., et al. (2017). "Non-alcoholic fatty liver disease and its relationship with cardiovascular disease and other extrahepatic diseases." Gut 66(6): 1138-1153.

Anstee, Q. M., et al . Progression of NAFLD to diabetes mellitus, cardiovascular disease or cirrhosis. Nat. Rev. Gastroenterol. Hepatol. (2013).

Obesity

Chronic

kidney

disease

CVD

Type 2

diabetes

Extrahepatic

neoplasia

Dyslipidaemia

11

▪ NAFLD is the most prevalent chronic liver

disease in the world.

▪ 25% adult population [95% CI: 22-29%]

▪ 1.9 billion people; 52 million in Europe

▪ Differences across regions, gender and age

▪ Higher prevalence among risk groups (T2DM,

obese)

Source: Younossi, Z. M. et al. Global epidemiology of nonalcoholic fatty liver disease — meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology (2016)

The prevalence of NAFLD

12

HEPAHEALTHBurden of liver disease in Europe

Age standardised mortality by aetiology in the most recent year available for each country

Source: Pimpin L et al. Burden of liver disease in Europe: Epidemiology and analysis of risk factors to identify prevention policies, J Hepatol. (2018).

13

Policy review countries and leads

14EASL INTERNATIONAL LIVER FOUNDATION

Michael Trauner

Sven Francque

Lyudmila Mateva

Ivana Mikolasevic

Emmelia Vounou

Riina Salupere

Georgios Papatheodoridis

Bela Hunyady

Suzanne Norris

Jonas Valantinas

Robert Flisiak

Liana Gheorghe

Marek Rac

Jean-François Dufour

Radan Brůha

Mette Nåmdal Vesterhus

Maja Thiele

Ieva Tolmane

Ger Koek

Austria

Belgium

Bulgaria

Croatia

Czech Republic

Denmark

Estonia

Greece

Hungary

Ireland

Latvia

Lithuania

Netherlands

Norway

Poland

Republic of Cyprus

Romania

Slovakia

Switzerland

MaltaFinland

Hannele Yki-Järvinen

Perttu Arkkila-

Luxemburg

Weber Joseph

France

Germany

Italy

Portugal

Slovenia

Spain

Sweden

UK

Vlad Ratziu

Helena Cortez-Pinto

Marko Korenjak

Katja Novak

Quentin M. Anstee

Frank Tacke

Giulio Marchesini

Manuel Romero-Gomez

Mattias Ekstedt

Response rate

15

Responses (29) No reponse (1)

France

Germany

Italy

Portugal

Slovenia

Spain

Sweden

UK

Austria

Belgium

Bulgaria

Croatia

Czech Republic

Denmark

Estonia

Finland

Greece

Hungary

Ireland

Latvia

Lithuania

Luxemburg

Netherlands

Norway

Poland

Republic of Cyprus

Romania

Slovakia

Switzerland

Malta

Policies and Guidelines

16

Does your country have any written

national or regional NAFLD/NASH

strategy/action plan?

EASL INTERNATIONAL LIVER FOUNDATION

100%

NO

17

45

%41%

7%

7%

34

%

52

%

7%

7%

42

%41

%

10%

7%

14

%

83

%

3%

15

%

85

%

10%

90

%

100%

100%

100%

Surveyed countries with a

strategy/action plan for:

Obesity:

Alcohol:

Cardiovascular disease:

Liver disease:

Diabetes:

Healthy habits / nutrition:

Is NAFLD/NASH

specifically

accounted for in

other relevant

disease strategy

/action plans?

NAFLD/NASH mentioned in

exiting strategy/action plan:

48%35%

7%10%

48%

35%

7%10%

93%

7%

Does your country have national clinical guidelines for the prevention, diagnosis and/or treatment of NAFLD/NASH?

18

• Overall, 35% of countries have national clinical

guidelines: Spain, Germany, Italy, UK, Belgium,

Czech Republic, Denmark, Poland, Romania and

Slovakia.

• Austria uses clinical guidelines from Germany

and Greece is currently developing them.

• Some countries (Bulgaria and Estonia) use

international guidelines.


35%

62%

3%

Yes No In development

Liver transplant

Is NAFLD/NASH specifically accounted for in other relevant national/regional disease clinical guidelines (CG)?

Dyslipidemia

Obesity

Diabetes

Alcohol

Ischemic heart

disease

Hypertension

End stage liver

disease / cirrhosis

Surveyed countries

with a CG for:NAFLD/NASH

mentioned in exiting CG:

Surveyed countries

with a CG for:

NAFLD/NASH mentioned

in exiting CG:

65%

28%

7%

62%21%

7%10%

86%

4%10%

48%

31%

14%7%

66%21%

3%10%

45%

41%

7%7%

24%

69%

7%

38%

52%

3%7%

11%

84%

5%

33%

67%

8%

88%

4%

7%

93%

95%

5%

8%

84%

8%

57%

43%

55%

45%

• Some countries

reported using

international CG or

having national/regional

CG in development.

Awareness

Do government funded awareness campaigns (in non-hospital/clinic settings) on healthy eating, healthy foods, physical activity, soft drink consumption etc, include any specific mention of any aspect of “liver health”?


• Countries that reported yes are Spain,

Slovenia, Croatia, Hungary, Latvia,

Luxemburg and Switzerland.

24%

72%

4%

Yes No Do not know


Is there any in-country civil society group focused on NAFLD?

• Countries that reported having in-country

civil society group focused on NAFLD are

Portugal, Netherlands and Switzerland.

10%

83%

4%3%

Yes No Do not know Missing

22

Monitoring and Data

Does your country have any national (not cohort or sub-national) disease

registries that includes NAFLD/NASH?

Spain, Portugal and Lithuania are the only

countries to report yes.


10%

90%

Yes No Do not know


Does your country have any regional or national NAFLD/NASH cohorts?

• Countries with regional/national NAFLD/NASH

cohorts are Spain, Germany, Sweden, UK,

Croatia, Netherlands, Slovakia and Switzerland.

• Some countries have cohorts followed in specific

centers (i.e. University hospitals).

28%

65%

7%

Yes No Do not know


Have there been any population-based epidemiological studies done to assess prevalence/ incidence of NAFLD/NASH in your country in the past 5 years?

Are there any ongoing nationwide epidemiological studies assessing the prevalence/incidence of NAFLD/NASH in your country?

Spain, France, Germany, Portugal,

Sweden, UK, Croatia, Finland.

Spain, Germany.

28%

69%

3%

Yes No Do not know

7%

86%

7%

Yes No Do not know

Prevention, Testing and Diagnosis

25

Do regional/national policy/guidelines specifically recommend screening of

NAFLD/NASH in patients with either obesity or diabetes or metabolic syndrome?


• Screening of NALFD in at least one of

these diseases is recommended in

Germany, Italy, UK, Austria, Belgium,

Bulgaria, Czech Republic, Lithuania,

Netherlands, Norway and Romania.

38%

55%

7%

Yes No Do not know

In your country, which healthcare provider is typically responsible for the care of NAFLD/NASH patients following diagnosis?


COUNTRY Gastroenterology Internal medicine Hepatology Primary care Multidisciplinary team Other

France x x

Germany x x x x x

Italy x x x x

Portugal x x x x x

Slovenia x x

Spain x x x

Sweden x x x

UK x x x x

Austria x x x

Belgium x x

Bulgaria x x x x x

Croatia x x

Czech Republic x x x

Denmark

Estonia x x x

Greece x x x x

Hungary x x x x

Ireland x x

Latvia

Lithuania x x x

Netherlands

Norway x x

Poland x x

Republic of Cyprus x x x x

Romania x x

Slovakia x

Swizerland x x x x

Luxemburg x x x

Finland x x

Treatment

Are structured lifestyle programmes aimed at NAFLD/NASH available?


• They are available in Germany, UK,

Belgium, Croatia, Czech Republic,

Hungary and Slovakia.

24%

72%

4%

Yes No Do not know

Moving forward: Creating policy/implementation index

28

▪ Why do we need an index and why do we want one?

• To rank and compare countries and use the index a lever to encourage

action on the matter

▪ This is a common tool in global public health.


Barriers: late presentation for care

Source: Mauss et al. BMC Med,

2017.

Sustainable Development Goals

30Source: https://sustainabledevelopment.un.org/, accessed 2 April 2019

https://sustainabledevelopment.un.org/

UHC – Universal Health Coverage

31

Source: https://www.who.int/universal_health_coverage/infographics/en/

▪ Everybody should receive full essential health

services, including health promotion and

prevention, treatment, rehabilitation and

palliative care

→ without financial hardship

▪Achieving UHC is one of the Sustainable

Development Goals

Conclusions

32

▪ A hidden epidemic with limited attention in health policies and clinical

guidelines, particularly in non-liver fields

▪ Few countries have government-funded awareness activities or civil society

groups addressing NAFLD/NASH.

▪ Policy levers such as the SDGs and UHC should be considered for raising

the profile of NAFLD/NASH

Acknowledgements

Study Group

Laurent Castera

Massimo Colombo

Gianluigi Condorelli

Giovanni Fattore

Loreta Kondili

Marko Korenjak

Giulio Marchesini

Vlad Ratziu

Maria Reig

Frank Tacke

Valerie Vilgrain

Country Leads

Mattias Ekstedt

Marko Korenjak

Katja Novak

Giulio Marchesini

Vlad Ratziu

Manuel Romero-Gomez

Frank Tacke

Michael Trauner

Sven Francque

Lyudmila Mateva

Ivana Mikolasevic

Radan Brůha

Hannele Yki-Järvinen

Perttu Arkkila

Maja Thiele

Riina Salupere

Georgios Papatheodoridis

Bela Hunyady

Suzanne Norris

Ieva Tolmane

Jonas Valantinas

Ger Koek

Mette Nåmdal Vesterhus

Robert Flisiak

Emmelia Vounou

Liana Gheorghe

Marek Rac

Jean-François Dufour

Weber Joseph

Co-PIs

Quentin Anstee

Helena Cortez-

Pinto

nafld policy review 2019 - virology education

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